2015-Metabolomics&Microbiome-infertility

Recruiting

• Conditions: Azoospermia, Nonobstructive

• Registration Number: NCT06181851
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.

Detailed Description

The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.

Furthermore, the study aims to assess if the blood and seminal alterations of infertile patients have similarities with the same fluids of elderly patients, validating from a metabolomic and microbiomic point of view the hypothesis of premature aging of infertile patients.

Study Timeline

• Study Start: 2016-06-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-26
• Last Update Posted: 2023-12-26
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 45

Inclusion Criteria

• diagnosis of idiopathic non-obstructive azoospermia
• fertile men (pregnancy within 12 months from the start of the couple's search)
• men known to have been fertile aged between 65 and 75 (pregnancy within 12 months of the couple starting searching)

Exclusion Criteria

• diagnosis of varicocele
• endocrine alterations
• chromosomal alterations
• known genetic alterations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic role of the blood and semen samples	Baseline	Metabolomics and microbiome signature fertile and infertile men predicting possible finding of spermatozoa

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Lombardy, Italy